MULTI-ACL: Multi-scale Modeling for Predictive Characterization of Ligaments and Grafts Behavior in ACL Reconstruction
Study Details
Study Description
Brief Summary
The objective of this clinical trial is provide in vivo data thus to model the ligament biomechanical behavior within the physiologically healthy joint and to use the implemented model to predict risk and success rates focusing on knee joint Anterior Cruciate Ligament (ACL) reconstruction. Current ACL surgery offers 3 alternatives: autografts, allografts and bioengineered grafts; the choice of the implant and its characteristics still remains a critical point. The knowledge of patient-specific joint and graft biomechanics is fundamental to reduce surgical revision rate and low functional outcome. This clinical trial will provide data coming from patient-specific biomechanics into a prognostic computational model, able to provide information on both the optimal customized reconstruction and graft status during the early rehabilitation phase. This patient-specific approach will lead to quicker return to sports activity, reducing also the possibility of early osteoarthritis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Single-Bundle Single-bundle ACL reconstruction |
Procedure: Anterior Cruciate Ligament Reconstruction
Reconstruction of the anterior cruciate ligament by means of the three reported techniques, namely single-bundle, single-bundle with extraarticular tenodesis and anatomic double-bundle.
|
| Single-Bundle+Lateral Plasty Single-bundle ACL reconstruction with lateral plasty |
Procedure: Anterior Cruciate Ligament Reconstruction
Reconstruction of the anterior cruciate ligament by means of the three reported techniques, namely single-bundle, single-bundle with extraarticular tenodesis and anatomic double-bundle.
|
| Double-Bundle Double-bundle ACL reconstruction |
Procedure: Anterior Cruciate Ligament Reconstruction
Reconstruction of the anterior cruciate ligament by means of the three reported techniques, namely single-bundle, single-bundle with extraarticular tenodesis and anatomic double-bundle.
|
Outcome Measures
Primary Outcome Measures
- Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics [At baseline]
Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones.
- Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics [4 months]
Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones.
- Clinical Assessment, Knee Joint Laxity, Kinematics and Dynamics [18 months]
Active movements will be acquired by dynamic Roentgen Stereophotogrammetric Analysis (RSA) before and after surgery; joint dynamics will be estimated by analyzing Ground Reaction Force, applying inverse dynamics modeling. Navigation system will intra-operatively acquire passive joint kinematics. Clinical assessement will be performed: subjective (KOOS, SF-12) and objective (IKDC, Marx) ones.
Secondary Outcome Measures
- Functional and Anatomical Model [at 4 months]
MRI scans with T2 mapping will be performed on each patient to acquire the anatomical features, define the cartilage and graft status.
- Functional and Anatomical Model [18 months]
MRI scans with T2 mapping will be performed on each patient to acquire the anatomical features, define the cartilage and graft status.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Primary ACL lesion
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Ability to read and sign the informed consent.
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Age between 16 and 50 years old
Exclusion Criteria:
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Prior surgeries at the same knee
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Grade II or higher lesions at the collateral ligaments
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Posterior Cruciate Ligament lesion
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Inflammatory arthritis or other forms systemic inflammatory diseases
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Local or systemic infections
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Any injury or condition that adversely affects the ability to walk or to participate to I/II level activities
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Previous or concomitant lesions at the contralateral knee
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Skeletal immaturity
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Other potential risk factors for the development of osteoarthritis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituto Ortopedico Rizzoli | Bologna | BO | Italy | 40136 |
Sponsors and Collaborators
- Istituto Ortopedico Rizzoli
- Ministry of Health, Italy
Investigators
- Principal Investigator: Stefano Zaffagnini, Prof, MD, Istituto Ortopedico Rizzoli
- Study Director: Nicola Francesco Lopomo, Prof, Istituto Ortopedico Rizzoli
- Study Chair: Cecilia Signorelli, PhD, Istituto Ortopedico Rizzoli
- Study Chair: Marco Bontempi, PhD, Istituto Ortopedico Rizzoli
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 0023352